Exercise PerformanceNCT06077019
Role of Lung Function for Exercise Capacity in Well-trained Individuals
A study testing Vilanterol and Fluticasone Furoate and Indacaterol and Mometasone Furoate in people with Exercise Performance, run by Morten Hostrup, PhD at 1 site in Denmark.
Trial summary
The purpose of the project is to investigate exercise performance in humans following prolonged inhalation of beta2-agonists vilanterol + fluticasone furoate or indacaterol + mometasone furoate Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance
- What is being tested?
- Vilanterol and Fluticasone Furoate and Indacaterol and Mometasone Furoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Oct 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-39
- Physically active > 5 h weekly
- Maximal oxygen consumption classified as high or very high
Who cannot join
- Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
- ECG abnormality
- ACQ score > 1.5
- Severe bronchial hyperreactivity as determined by mannitol test
- FEV1/FVC ratio < 0.7 determined with spirometry
- Chronic illness determined to be a potential risk for participant during study
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- In chronic treatment with medication that may interfere with study results
- Pregnancy
- Smoker
- Blood donation during the past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
August Krogh Building
Copenhagen, 2100
Morten Hostrup, PhD
About this study
Official title: Role of Lung Function, Airway Inflammation and Bronchial Hyper Reactivity for Exercise Capacity in Well-trained Individuals
The purpose of the project is to investigate exercise performance in humans following prolonged inhalation of beta2-agonists vilanterol + fluticasone furoate or indacaterol + mometasone furoate
- Conditions
- Exercise Performance
- Being tested
- Vilanterol and Fluticasone Furoate, Indacaterol and Mometasone Furoate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vilanterol and Fluticasone FuroateDrug
Participants inhale 25 µg vilanterol + fluticasone furoate daily
Indacaterol and Mometasone FuroateDrug
Participants inhale 125 µg indacaterol + mometasone furoate daily
PlaceboDrug
Participants inhale placebo daily
| Study group | Role | What they receive |
|---|---|---|
| Vilanterol | Experimental | Participants inhale vilanterol + fluticasone furoat Receives: Drug: Vilanterol and Fluticasone Furoate |
| Indacaterol | Experimental | Participants inhale indacaterol + mometasone furoate Receives: Drug: Indacaterol and Mometasone Furoate |
| Placebo | Placebo comparator | Participants inhale placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity during a time trial
Mean power output measured in Watts during a time trial on a bike ergometer
Measured: Through study completion, an average of 8 weeks
Secondary outcomes (1)
Lung function
Forced expiratory volume in 1 second (FEV1) measured by spirometry before and after time trial with and without beta2-agonist induced bronchodilation
Measured: Through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start3 Oct 2023
- Primary completion15 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morten Hostrup, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Morten Hostrup, PhD, University of Copenhagen
- Investigators
- Morten Hostrup, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077019
- Sponsor's protocol ID
- CHRON_INDAC_VIL
- Status last verified
- Apr 2025
- First submitted
- 20 Sep 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data set will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lung Function, Airway Inflammation and Bronchial Hyper Reactivity for Exercise Capacity in Well-trained Individuals
- ClinicalTrials.gov ID
- NCT06077019
- Acronym / sponsor ID
- CHRON_INDAC_VIL
- Conditions
- Exercise Performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Morten Hostrup, PhDUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the project is to investigate exercise performance in humans following prolonged inhalation of beta2-agonists vilanterol + fluticasone furoate or indacaterol + mometasone furoate
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vilanterol | Experimental | Drug: Vilanterol and Fluticasone FuroateParticipants inhale vilanterol + fluticasone furoat |
| Indacaterol | Experimental | Drug: Indacaterol and Mometasone FuroateParticipants inhale indacaterol + mometasone furoate |
| Placebo | Placebo comparator | Drug: PlaceboParticipants inhale placebo |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-39
- Physically active > 5 h weekly
- Maximal oxygen consumption classified as high or very high
Key exclusion criteria (10 listed)
- Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
- ECG abnormality
- ACQ score > 1.5
- Severe bronchial hyperreactivity as determined by mannitol test
- FEV1/FVC ratio < 0.7 determined with spirometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vilanterol and Fluticasone FuroateParticipants inhale 25 µg vilanterol + fluticasone furoate daily | Drug | Vilanterol |
| Indacaterol and Mometasone FuroateParticipants inhale 125 µg indacaterol + mometasone furoate daily | Drug | Indacaterol |
| PlaceboParticipants inhale placebo daily | Drug | Placebo |
Primary outcome
Exercise capacity during a time trial
Time frame: Through study completion, an average of 8 weeks
Mean power output measured in Watts during a time trial on a bike ergometer
1 secondary outcome
Lung function
Time frame: Through study completion, an average of 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Yes. Deidentified data set will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Morten Hostrup, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vilanterol and Fluticasone Furoate and Indacaterol and Mometasone Furoate in people with Exercise Performance, run by Morten Hostrup, PhD at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morten Hostrup, PhD (+4535321595, mhostrup@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity during a time trial (time frame: Through study completion, an average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025; AzTrials last refreshed its copy on 1 Nov 2026.